Hypomelanotic Disorder Clinical Trials

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Evaluation of Laser-assisted Drug Delivery of Bimatoprost for the Treatment of Hypertrophic Scar Hypopigmentation: A Within Patient-Controlled Trial in Skin of Color

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Patients who have hypo-pigmented burn scar will have two scars chosen and randomized to treated scar and control scar. The subject will then have both scars treated with fractional ablative CO2 laser (FLSR). The treated scar will have bimatoprost delivered through the laser channels, while the control will have the vehicle (normal saline) only delivered. The treatment will continue for 14 days with twice daily application. The scars will then be monitored at a 2-week follow-up visit where levels of melanin will be evaluated. Tissue punch biopsies will also be used to evaluate the mechanism of action of bimatoprost. Treatment will occur for 6 sessions at 4-6 week intervals including follow- up visits and evaluations.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Cutaneous trauma resulting in hypopigmented scar

• 2 different hypopigmented scars (at least 30cm2 each) with at least 2 inches of normal skin, hyperpigmented scar, or hypopigmented scar separating each hypopigmented study site scar

Locations
United States
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Contact Information
Primary
Alison Ross, BA
fbsrlresearch@medstar.net
202-877-5170
Time Frame
Start Date: 2023-07-18
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 25
Treatments
Experimental: Treatment
Bimatoprost will be delivered to the scars using laser-assisted drug delivery in this arm
Sham_comparator: Control
Saline control will be delivered to the scars using laser-assisted drug delivery in this arm
Related Therapeutic Areas
Sponsors
Leads: Medstar Health Research Institute
Collaborators: Latham Fund

This content was sourced from clinicaltrials.gov